Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

A Randomized, Multicenter, Parallel Group, Dose-Ranging Study to Evaluate the Safety and Tolerability of SPN-810 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and Persistent Serious Conduct Problems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626236
• Other study ID #: 810P201
• Status: Completed
• Phase: Phase 2
• First received: February 20, 2008
• Last updated: January 18, 2013
• Start date: September 2008
• Est. completion date: October 2009

Study information

• Verified date: January 2013
• Source: Supernus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

It is hypothesized that, when given at the lowest effective dose, the favorable side effect profile combined with it's lower propensity for weight gain would make SPN-810 a candidate for treatment of persistent serious conduct problems in pediatric subjects with ADHD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

1. Healthy pediatric male or female subjects, age 6 to 12 years.

2. Diagnostic and Statistical Manual of Mental Disorders - IV -Text Revision (DSM-IV-TR) diagnosis of ADHD.

3. NCBRF-TIQ disruptive behavior disorder subscale 27 or greater at baseline; AND a score of 2 or more on at least 1 of the following 3 items of the conduct problem subscale: knowingly destroys property, gets in physical fights, physically attacks people.

4. IQ greater than 71.

Exclusion Criteria:

1. Current or lifetime diagnosis of bipolar disorder, post-traumatic stress disorder, personality disorder, or psychosis not otherwise specified.

2. Currently meeting DSM-IV-TR criteria for major depressive disorder, obsessive compulsive disorder, or pervasive developmental disorder.

3. Any other anxiety disorder as primary diagnosis.

4. Use of anticonvulsants, antidepressants, lithium, carbamazepine, valproic acid, or cholinesterase inhibitors within 2 weeks of baseline.

5. Unstable endocrinological or neurological conditions which confound the diagnosis or are a contraindication to treatment with antipsychotics.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Conduct Disorder
• Disease
• Hyperkinesis

Intervention

Drug:
• SPN-810
capsule taken three times a day
• SPN-810
capsule taken TID
• SPN-810
capsule taken TID
• SPN-810
capsule taken TID

Locations

Country	Name	City	State
United States	Northwest Clinical Trials	Bellevue	Washington
United States	Florida Clinical Research Center	Bradenton	Florida
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	IPS Research	Oklahoma City	Oklahoma
United States	CNS Healthcare	Orlando	Florida
United States	Alliance Research Group	Richmond	Virginia
United States	The Psychopharm Research Cntr - LSU Dept of Psychiatry	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Supernus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety scales (Simpson-Angus, Barnes Akathisia, AIMS)		weekly for duration of treatment	Yes
Secondary	Nisonger Child Behavior Rating Form - TIQ		screening, then weekly and at final visit	No